FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Controls Found Lacking at Contract Manufacturer

Dec. 14, 2018
A A

Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during a Sept 10 to Sept. 18 inspection of the firm’s Salt Lake City, Utah, facility.

The inspector reviewed data for certain PCMX Scrub products and found 52 events listed as a deleted result.

The firm’s quality director and a lab analyst were “unable to explain what ‘deleted result’ meant and they were unable to provide records or documentation explaining the events,” the 483 said.

View today's stories